Evaluation of the LightSheer HS Hand Piece as Compared to the LightSheer ET Hand Piece for the Intended Use of Hair Removal and Permanent Hair Reduction

This study has been completed.
Sponsor:
Information provided by:
Lumenis Ltd.
ClinicalTrials.gov Identifier:
NCT00657085
First received: April 8, 2008
Last updated: December 10, 2008
Last verified: December 2008
  Purpose

To observe the qualitative comparison of follicular damage between treatment with the LightSheer Duet hand pieces (ET and HS) as assessed by horizontal biopsy.


Condition
Laser Hair Removal

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the LightSheer HS Hand Piece as Compared to the LightSheer ET Hand Piece for the Intended Use of Hair Removal and Permanent Hair Reduction

Further study details as provided by Lumenis Ltd.:

Primary Outcome Measures:
  • Follicular damage assessed by histology [ Time Frame: first visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of permanent hair reduction between ET and HS handpieces [ Time Frame: 2 month follow up visit ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biopsied hair follicles retained and analzed through horizontal sectioning and viability staining


Estimated Enrollment: 5
Study Start Date: March 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

5 Adult male subjects that have sought laser back hair removal

Criteria

Inclusion Criteria:

  1. Healthy male adult, 18 years of age or older with skin type I-V;
  2. Having a suitable treatment area for hair removal with brown or black hair (no gray);
  3. Able and willing to comply with the treatment/follow-up schedule and requirements;
  4. Able to read, understand and provide written Informed Consent.

Exclusion Criteria:

  1. Showing symptoms of hormonal disorders, as per the Investigator's discretion;
  2. Use of oral isotretinoin (Accutane®) within 6 months, or off label use of topical isotretinoin in immediate treated area or in its proximity within 3 months, of study enrollment or during the course of the study;
  3. Prior skin treatment with laser or other devices on the same treated areas prior to study enrollment or during the course of the study;
  4. Adverse reaction to the treatment gel to be used in the evaluation;
  5. History of keloid formation or poor wound healing in a previously injured skin area;
  6. Significant skin conditions affecting treated area or inflammatory skin conditions;
  7. Open laceration, abrasion, active cold sores or herpes sores on area to be treated;
  8. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications;
  9. Having a bleeding disorder or taking anticoagulation medications within the preceding 6 months;
  10. Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the area to be treated;
  11. Significant concurrent illness, such as diabetes, lupus, epilepsy or cardiac disorders, which might be aggravated as a result of treatment;
  12. Unable or unlikely to refrain from tanning, including the use of tanning booths, tanning spray or cream, during the course of the evaluation;
  13. Photosensitivity disorder that can be exacerbated by infrared light;
  14. Tattoos in the treatment areas;
  15. Dysplastic nevi in the treatment areas;
  16. Allergy or history of an allergy to the topical anesthetic used.
  17. Participation in a study of another device or drug within 3 months prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria;
  18. Mentally incompetent, prisoner or evidence of active substance or alcohol abuse;
  19. Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00657085

Locations
United States, California
Seaver Soon
San Diego, California, United States
Sponsors and Collaborators
Lumenis Ltd.
Investigators
Principal Investigator: Seaver Soon, MD Scripps Dermatology
  More Information

No publications provided

Responsible Party: Chris Clark, Lumenis
ClinicalTrials.gov Identifier: NCT00657085     History of Changes
Other Study ID Numbers: LUM-ABU-HSET-0607-02
Study First Received: April 8, 2008
Last Updated: December 10, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Lumenis Ltd.:
Laser hair removal

ClinicalTrials.gov processed this record on October 23, 2014